IT/CSV/CSA|CSV Automation|QA Validation Expert|Specialist Batch Record |QMS

I ensured ongoing compliance of ERP applications with GxP and GDPR requirements. CSV Project Manager: responsible for validation strategies and management of relevant IT systems Preparation and review of CSV documents in accordance with standard operating procedures, laws, and guidelines I contributed to change management, gap resolution, and CAPA in close collaboration with stakeholders from IT, quality, and commercial departments I served as subject matter expert (SME) for ERP compliance during internal audits, supplier audits, and health authority inspections. I supported ERP system validation activities, including validation planning, requirements gathering, design review, test planning and execution, and validation report writing. I was responsible for writing documentation related to the validation lifecycle and deviation management. Application of a risk-based methodology, including software assurance concepts (CSA) Support the development of requirements for the operational phase of the ERP system, including change management, user access review...

Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements. Support the periodic review of software applications used in GMP processes, including those for quality control, production, and supply chain. Act as Quality SME by Ensuring the Link between the Group & the Quality Manager Act as SME & Support for Quality Risk Assessment, Share Expertise & Knowledge with Business Owners & Stakeholders. Review of deliverables on project/department level in conjunction with issues that are affecting the quality of the clinical deliverables to ensure quality standards are achieved. Assisting in investigation and detection of the quality issues and development of CAPAs for the project/portfolio/department when required. Provide leadership for preparation and execution of external parties inspections, audits. Scheduling and managing internal and external meetings, producing presentation and generating meeting minutes. Preparation and distribution of regular status report Author, review and/or approve applicable CSV documentation. Ensure that all Validation Activities are carried out, reported & Closed According to Validation Plan. ➜ Veeva Vault (QualityDocs,QualityOne) ➜ Oracle Argus Safety

SV Expert / LIMS AMPLEXOR